FDA Adverse Event
Injury
Summary report: N
DEPUY PINNACLE ACETABULAR CUP, 52-MM
MDR report key: 2973823
·
Received February 16, 2013
Report
- Report Number
- MW5029021
- Event Type
- Injury
- Date Received
- February 16, 2013
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2005. I RECEIVED THE DEPUY PINNACLE ACETABULAR CUP, 52-MM. ABOUT 5 YEARS AFTER THE DATE OF IMPLANTATION, I BEGAN EXPERIENCING SEVERE PAIN THAT GOT PROGRESSIVELY WORSE UNTIL MY REVISION SURGERY ON (B)(6) 2011. THE PAIN SEVERELY LIMITED MY MOBILITY. I COULD NOT BEND, LIFT, USE STAIRWAY AND HAD DIFFICULTY WALKING. DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69993 | DEPUY PINNACLE ACETABULAR CUP, 52-MM | XETAL-ON-METAL HIP IMPLANT | KWA | DEPUY ORTHOPAEDICS, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R| S | IN-PATIENT THERAPY, (B)(6) 2011 |